Poison Help Line Guidelines
AAPCC Guidelines for Industry: Product Labeling
The phone number 1-800-222-1222 connects callers to their local poison control center anywhere in the United States. Callers receive free, confidential, expert medical help, 24/7/365, whether a caller has an emergency or just needs information. The American Association of Poison Control Centers (AAPCC) and the U.S. Health Resources and Services Administration (HRSA) work together to ensure the number and poison centers are used appropriately.
Can I put the poison control number on my company’s product label?
You may put the 1-800-222-1222 phone number on your product label at no charge provided you comply with the below wording AND list your product with Poisindex.
The number (1-800-222-1222) must appear with the words: “If swallowed” or “In case of poisoning” or “If over-exposure occurs ...” followed by “call your poison control center at 1-800-222-1222." Any other label wording must be specifically approved by AAPCC. In no case will wording be approved if the words “poison control center” are not included. Putting 1-800-222-1222 on your product label in no way implies AAPCC endorsement of the product. Any company placing the number on their product automatically agrees to indemnify AAPCC and all U.S. poison control centers responding to calls from consumers.
How do I list my company’s product with Poisindex®?
Poisindex® is a computer product database used by poison centers that contains information on products, such as ingredients. It is maintained by Truven Health Analytics Inc. Listing your product with Poisindex is necessary so that poison centers have adequate information to accurately manage incoming calls about your product. This listing is free. To list your product with Poisindex:
- Complete the Poisindex Information System Product Information Form in the lower right hand corner of this page.
- Contact Truven Health Analytics directly with any questions about the forms at 1-800-642-6339.
- Allow at least six months from submitting product information until it becomes available to poison centers through Poisindex.
- Provide revisions if product formulations are changed or new products are introduced. Attempting to provide emergency poisoning treatment recommendations using incorrect or inadequate ingredient information can seriously compromise patient outcomes and even cause unnecessary deaths. Each company must take responsibility for providing up-to-date product information to Poisindex.
Do I have to list the words “poison control center”?
Some product manufacturers are hesitant to associate the words “poison control center” with their product. Manufacturers of products who would like to use poison control center services but not use the words “poison control center” may contract directly with a poison center for individual services.
Manufacturers are not permitted to use the 1-800-222-1222 phone number without these words because poison centers are not adequately staffed or prepared to handle non-emergency product questions such as questions about product replacement or malfunction. These calls interfere with poison centers’ ability to respond to true emergencies.
Why would I directly contract with a poison center?
For some companies, there are advantages to directly contracting with an individual poison control center for services rather than using the national poison control number on their label. Companies may prefer to contract with an individual poison center if they need:
a) Responses to non-emergency and non-poisoning product inquiries and consumer complaints,
b) Customer-specific (patient identifying) data for each caller,
c) Additional data fields beyond those included in AAPCC’s NPDS,
d) Submission of specialized forms to regulatory agencies (Medwatch, FIFRA, etc.)
e) Consulting services for labeling, product safety, or regulatory issues.
Companies with contract service should follow instructions from their contracted poison center regarding wording and phone number use on their product labels. This industry contract service is available for a charge. If interested in contracting with an individual poison control center for this service, contact AAPCC for a list of interested accredited poison centers.
Am I legally required to reference poison control on my label?
AAPCC doesn’t create legal requirements, so we can’t answer this question. This answer may vary depending on the type of product your company manufacturers. As well, there may be both federal laws and state laws in effect regarding packaging, labeling, and registering of products. If you are conducting a search for this information on a federal level we recommend starting with the U.S. Environmental Protection Agency (EPA), or the U.S. Food and Drug Administration (FDA).
Can I obtain data from poison centers about my company’s product?
Calls to poison control centers are coded by each poison center as they happen and are uploaded into a national database owned by AAPCC called the National Poison Data System (NPDS). Calls are uploaded every 13 minutes, meaning our data is real-time.
AAPCC publishes basic data on general categories free of charge in annual reports each year. Additional information about any specific products or chemical formulations, without patient identifiers, can be purchased from AAPCC in the form of custom reports. Poisoning case data are only available to the company that owns the product, to AAPCC, and to regulatory agencies. (As a rule, AAPCC won’t sell Pfizer product information to Novartis or vice versa.)
Report costs support AAPCC, NPDS, and the U.S. poison control center network. AAPCC is a non-profit organization. For more information about custom reports, or for a complete listing of free annual reports, visit AAPCC at www.aapcc.org or contact us at (703) 894-1858 or email@example.com. Annual reports are only available by electronic download at this time.